A “major” healthcare manufacturer and its wholesaler have been fined more than £550,000 for selling defective syringes, one of which contributed to a man’s death, the MHRA has announced.
Cheshire-based manufacturer Calea UK and its sister company, licensed wholesaler Fresenius Kabi, were convicted at Sheffield Crown Court on Thursday (July 9) of playing a “major contributory” role in a patient death, the MHRA said.
The companies supplied a batch of syringes for diabetics that contained no insulin to the Northern General Hospital in Sheffield in 2010, the medicines watchdog said. After receiving one of the syringes, diabetic patient Neil Judge from Barnsley suffered multi-organ failure due to his body being deprived of insulin for more than 13 hours.
The MHRA led the prosecution at Sheffield Crown Court, where Frenesius Kabi was fined £500,000 plus costs of £5,900 and Calea UK had to pay £50,000 plus costs for breaching sections 64(1) and 67(2) of the Medicines Act 1968.
Not an isolated incident
The court heard that the supply of faulty insulin syringes was not an “isolated incident” and Calea UK had manufactured a batch of syringes for treating infections that contained three times the prescribed daily dose of the antibiotic tobramycin.
The fault came to light after a cystic fibrosis patient at the Royal Shrewsbury Hospital described experiencing a “fizzing sensation” after being administered the syringe in 2011. The patient suffered no lasting effects, the MHRA said.
The two incidents occurred despite MHRA officials having previously highlighted “deficiencies” with the companies’ ability to identify defective products following a series of inspections of the companies’ operating site in Runcorn, the watchdog said.
MHRA head of enforcement Alastair Jeffrey said the two companies were “equally responsible...for a major contributing factor in the tragic death of Neil Judge, who was deprived of the vital insulin his body needed”.
The patient who had received an overdose of tobramycin had “thankfully” been “relatively unharmed", Mr Jeffrey said. “The consequences could have been more serious had hospital staff not responded to his complaints,” he stressed.
“I hope this case serves as a clear reminder to others [that the] MHRA will not hesitate to take enforcement action when serious failings occur,” he added.